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3V-L DL: Pediatric Difficult Intubation

Sponsor
International Institute of Rescue Research and Education (Other)
Overall Status
Unknown status
CT.gov ID
NCT02295670
Collaborator
(none)
180
Enrollment
1
Location
2
Arms
30
Duration (Days)
182.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR). These guidelines also suggest that skilled operators should be able to secure the airway without interrupting chest compression. The aim of the study was to compare time and success rates of the Vividtrac video-laryngoscope and the Miller laryngoscope for emergency intubation during simulated pediatric CPR.

Condition or Disease Intervention/Treatment Phase
  • Device: Vividtrac
  • Device: MIL
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Can the Vividtrac Laryngoscope Rival the Miller Laryngoscope for Child Tracheal Intubation During Chest Compression in a Manikin? A Randomized Crossover Trial.
Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Endotracheal intubation without chest compressions

Endotracheal intubation of mannikin during resuscitation without chest compressions.

Device: Vividtrac
video-laryngoscopy

Device: MIL
direct-laryngoscopy
Other Names:
  • miller larygoscopy

    		•
    Experimental: Endotracheal intubation with uninterrupted chest compressions

    Endotracheal intubation of mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).

    Device: Vividtrac
    video-laryngoscopy

    Device: MIL
    direct-laryngoscopy
    Other Names:
  • miller larygoscopy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to intubation [1 day]

      time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure

    Secondary Outcome Measures

    1. Success of intubation [1 day]

      effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations. Visual Analog scale (VAS) score

    2. Cormack-Lehane grading [1 day]

      self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Give voluntary consent to participate in the study

    • Paramedic student

    Exclusion Criteria:

    • Not meet the above criteria

    • Wrist or Low back diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 International Institute of Rescue Research and Education Warsaw Masovie Poland 03-122

    Sponsors and Collaborators

    • International Institute of Rescue Research and Education

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
    ClinicalTrials.gov Identifier:
    NCT02295670
    Other Study ID Numbers:
    • ETI/2014/51
    First Posted:
    Nov 20, 2014
    Last Update Posted:
    Nov 20, 2014
    Last Verified:
    Nov 1, 2014
    Additional relevant MeSH terms:
    Heart Arrest

    Study Results

    No Results Posted as of Nov 20, 2014